Cleared Traditional

K060462 - NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN...

K060462 is an FDA 510(k) clearance for NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN..., manufactured by Lab Vision Corp.. The device is a Class 2 Pathology device with product code MXZ cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K060462 · Lab Vision Corp. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
61d
Days
Class 2
Risk

K060462 is an FDA 510(k) clearance for the NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR ANTIBODY (CLONE.... Classified as Immunohistochemistry Assay, Antibody, Progesterone Receptor (product code MXZ), Class II - Special Controls.

Submitted by Lab Vision Corp. (Fremont, US). The FDA issued a Cleared decision on April 24, 2006 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.1860 - the FDA pathology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lab Vision Corp. devices

FDA 510(k) Submission Details - K060462

510(k) Number K060462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2006
Decision Date April 24, 2006
Days to Decision 61 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 77d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MXZ Device Classification - Class 2, Special Controls

Product Code MXZ Immunohistochemistry Assay, Antibody, Progesterone Receptor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.1860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Pathology devices follow this clearance model.

Regulatory Peers - MXZ Immunohistochemistry Assay, Antibody, Progesterone Receptor

Devices cleared under the same product code (MXZ) and FDA review panel - the closest regulatory comparables to K060462.
BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format).
K193393 · Leica Biosystems Newcastle, Ltd. · Mar 2020
BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody
K183102 · Leica Biosystems Newcastle, Limited · Dec 2018
DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAINING
K020023 · Dako Corp. · Feb 2002
VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6)
K990618 · Ventana Medical Systems, Inc. · Jul 1999